Spinal Cord Stimulation

Transcription

Spinal Cord Stimulation
Status
Active
Medical and Behavioral Health Policy
Section: Surgery
Policy Number: IV-74
Effective Date: 03/23/2015
Blue Cross and Blue Shield of Minnesota medical policies do not imply that members should not receive specific services
based on the recommendation of their provider. These policies govern coverage and not clinical practice. Providers are
responsible for medical advice and treatment of patients. Members with specific health care needs should consult an
appropriate health care professional.
SPINAL CORD STIMULATION
Description:
Spinal cord stimulation (SCS) delivers low voltage electrical
stimulation to the dorsal columns of the spinal cord to block the
sensation of pain. The neurophysiology of pain relief after SCS is
uncertain, but may be related to either activation of an inhibitory
system or blockage of facilitative circuits.
Conventional SCS devices consist of several components: 1) a
multi-electrode lead that delivers the electrical stimulation to the
spinal cord; 2) an extension wire that conducts the electrical
stimulation from the power source to the lead; and 3) a power source
that generates the electrical stimulation. The power source (i.e.,
battery) can be surgically implanted or worn externally over an
implanted radiofrequency receiver. Totally implantable systems are
most commonly used. The patient's pain distribution pattern dictates
the placement level of the stimulation lead in the spinal cord. The
pain pattern may also influence the type of device used (e.g., a lead
with more electrodes may be selected for those with complex pain
patterns, such as pain extending from the limbs to the trunk or
bilateral pain).
In 2014, the U.S. Food and Drug Administration (FDA) granted
510(k) clearance to the Freedom SCS system (Stimwave
Technologies, Inc.) for treating chronic, intractable pain of the trunk
and/or lower limbs, including unilateral or bilateral pain. The
Freedom SCS system is comprised of an implantable, one-piece,
wireless stimulator and an externally worn transmitter to power the
device. The Freedom stimulator is much smaller than conventional
SCS devices, allowing it to be implanted near the spinal nerves via
injection through a standard needle.
Implantation of a SCS device is typically a two-step process. Initially,
the device is temporarily implanted in the epidural space, allowing a
trial period of stimulation. Once treatment effectiveness is confirmed
(defined as at least 50% reduction in pain), the device is
permanently implanted. Successful SCS may require extensive
programming of the neurostimulators to identify the optimal electrode
combinations and stimulation of channels. Computer-controlled
programs are often used to assist the physician in studying the
various programming options when complex systems are used.
SCS has been used in a wide variety of chronic refractory pain
conditions, including failed back surgery syndrome, arachnoiditis,
and complex regional pain syndrome (i.e., chronic reflex sympathetic
dystrophy). There has also been interest in SCS as a treatment of
critical limb ischemia, primarily in patients who are poor candidates
for revascularization, and in patients with refractory chest pain.
Definitions:
Neuropathic pain: Any disruption (e.g., damage, injury, disease,
dysfunction) of the peripheral or central nervous system that results in
symptoms such as burning or piercing/stabbing sensations and which
is not alleviated by opioids given at clinical dosages.
Policy:
I.
Spinal cord stimulation may be considered MEDICALLY
NECESSARY for the treatment of severe and chronic pain of
the trunk or limbs when ALL of the following criteria are met:
A. Documented history and diagnosis appropriate to this form
of therapy, including documented evidence of neuropathic
pain; AND
B. Documentation that all other appropriate conservative
medical and invasive treatment measures have been tried
and exhausted (e.g., chronic pain management programs;
conservative primary care case management; medications
such as anti-depressants, anti-spasmodics, narcotics, antiinflammatories; trigger point injections; nerve blocks and
epidural blocks); AND
C. Documentation from the patient’s primary care physician or
a mental health professional (i.e., psychiatrist or PhD
psychologist) that any identified mental health or chemical
dependency disorders are being or have been addressed;
AND
D. Where indicated, completion of a comprehensive physical
therapy evaluation; AND
E. No medical contraindications to the implantation/spinal
surgery (e.g., drug allergies, sepsis, coagulopathy, inability
to cope with the technology); AND
F. Demonstration of at least 50% pain relief with a temporarily
implanted electrode precedes permanent implantation.
II.
Spinal cord stimulation is considered INVESTIGATIVE for all
other indications, including but not limited to, treatment of:
A. Critical limb ischemia, as a technique to forestall
amputation;
B. Refractory angina pectoris;
C. Cancer-related pain.
Coverage:
Blue Cross and Blue Shield of Minnesota medical policies apply
generally to all Blue Cross and Blue Plus plans and products. Benefit
plans vary in coverage and some plans may not provide coverage for
certain services addressed in the medical policies.
Medicaid products and some self-insured plans may have additional
policies and prior authorization requirements. Receipt of benefits is
subject to all terms and conditions of the member’s summary plan
description (SPD). As applicable, review the provisions relating to a
specific coverage determination, including exclusions and limitations.
Blue Cross reserves the right to revise, update and/or add to its
medical policies at any time without notice.
For Medicare NCD and/or Medicare LCD, please consult CMS or
National Government Services websites.
Refer to the Pre-Certification/Pre-Authorization section of the Medical
Behavioral Health Policy Manual for the full list of services,
procedures, prescription drugs, and medical devices that require Precertification/Pre-Authorization. Note that services with specific
coverage criteria may be reviewed retrospectively to determine if
criteria are being met. Retrospective denial of claims may result if
criteria are not met.
Coding:
The following codes are included below for informational purposes
only, and are subject to change without notice. Inclusion or exclusion
of a code does not constitute or imply member coverage or provider
reimbursement.
CPT:
63650 Percutaneous implantation of neurostimulator electrode array,
epidural
63655 Laminectomy for implantation of neurostimulator electrodes,
plate/paddle, epidural
63685 Insertion or replacement of spinal neurostimulator pulse
generator or receiver, direct or inductive coupling
0282T Percutaneous or open implantation of neurostimulator
electrode array(s), subcutaneous (peripheral subcutaneous field
stimulation), including imaging guidance, when performed, cervical,
thoracic or lumbar; for trial, including removal at the conclusion of trial
period
0283T Percutaneous or open implantation of neurostimulator electrode
array(s), subcutaneous (peripheral subcutaneous field stimulation),
including imaging guidance, when performed, cervical, thoracic or
lumbar; permanent, with implantation of a pulse generator
HCPCS:
L8679 Implantable neurostimulator, pulse generator, any type
L8680 Implantable neurostimulator electrode, each
L8685 Implantable neurostimulator pulse generator, single array,
rechargeable, includes extension
L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687 Implantable neurostimulator pulse generator, dual array,
rechargeable, includes extension
L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
ICD-9 Procedure:
03.93 Implantation or replacement of spinal neurostimulator lead(s)
86.94 Insertion or replacement of single array neurostimulator pulse
generator, not specified as rechargeable
86.95 Insertion or replacement of multiple array neurostimulator pulse
generator, not specified as rechargeable
86.97 Insertion or replacement or single array rechargeable
neurostimulator pulse generator
86.98 Insertion or replacement of multiple array (two or more)
rechargeable neurostimulator pulse generator
ICD-10 Procedure:
00HV3MZ Insertion of Neurostimulator Lead into Spinal Cord,
Percutaneous Approach
0JH60BZ Insertion of Single Array Stimulator Generator into Chest
Subcutaneous Tissue and Fascia, Open Approach
0JH60DZ Insertion of Multiple Array Stimulator Generator into Chest
Subcutaneous Tissue and Fascia, Open Approach
0JH60CZ Insertion of Single Array Rechargeable Stimulator Generator
into Chest Subcutaneous Tissue and Fascia, Open Approach
0JH60EZ Insertion of Multiple Array Rechargeable Stimulator
Generator into Chest Subcutaneous Tissue and Fascia, Open
Approach
Policy
History:
Developed June 1, 1990
Most recent history:
Reviewed January 11, 2012
Reviewed January 9, 2013
Reviewed/Updated, no policy statement changes January 8, 2014
Revised January 14, 2015
Cross
Reference:
Peripheral Nerve Stimulation of the Trunk or Limbs for Treatment of
Pain, II-149
Current Procedural Terminology (CPT®) is copyright 2014 American Medical
Association. All Rights Reserved. No fee schedules, basic units, relative values, or
related listings are included in CPT. The AMA assumes no liability for the data
contained herein. Applicable FARS/DFARS restrictions apply to government use.
Copyright 2015 Blue Cross Blue Shield of Minnesota.